Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206647
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription AB No No
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/2016 ORIG-1 Approval STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206647Orig1_Approval_Pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2019 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

ALOSETRON HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 211621 EYWA PHARMA
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 200652 HIKMA
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 206113 PAR PHARM INC
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 209180 RISING
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 211621 EYWA PHARMA
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 200652 HIKMA
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 206113 PAR PHARM INC
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 209180 RISING
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

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